Videoin

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VIDEYIN (VIDEYIN)

Composition:

Active substance: cholecalciferol;

1 capsule contains cholecalciferol 12.5 μg (vitamin D3 – 500 IU) or 25 μg (vitamin D3 – 1000 IU), or 100 μg (vitamin D3 – 4000 IU);

Excipients: α-tocopheryl acetate; medium-chain triglycerides;

Capsule shell: gelatin, glycerin.

Pharmaceutical form. Soft capsules.

Main physicochemical properties:

Capsules of 12.5 μg (500 IU): soft gelatin capsules in the shape of a tubatin, with an elongated neck resembling a "fish tail", with a seam, light yellow in color, filled with a colorless or slightly yellowish oily liquid;

Capsules of 25 μg (1000 IU): soft gelatin capsules in the shape of a "bottle", with a seam, light yellow in color, filled with a colorless or slightly yellowish oily liquid;

Capsules of 100 μg (4000 IU): soft gelatin capsules of oval shape, with a seam, light yellow in color, filled with a colorless or slightly yellowish oily liquid.

Pharmacotherapeutic group. Vitamins. Vitamin D and its analogues. Cholecalciferol. ATC code A11CC05.

Pharmacological properties.

Pharmacodynamics.

Vitamin D3 is the active antirachitic factor. The most important function of vitamin D3 is the regulation of calcium and phosphate metabolism, which promotes proper skeletal mineralization and growth.

Vitamin D3 is a natural form of vitamin D produced in animals and humans. Compared to vitamin D2, it has approximately 25 % higher activity. The active form is calcitriol (1,25-dihydroxy-vitamin D3), the product of two sequential hydroxylations occurring in the liver and kidneys.

Vitamin D3 is essential for the function of the parathyroid glands, intestine, kidneys, and skeletal system. It plays a crucial role in the absorption of calcium and phosphates from the intestine, in the transport of mineral salts, and in the process of bone calcification. It regulates the renal excretion of calcium and phosphates. The concentration of calcium ions affects several vital biochemical processes, contributing to the maintenance of skeletal muscle tone, participating in nerve impulse conduction, and influencing blood coagulation. Vitamin D3 also participates in immune system function and affects lymphokine production.

Deficiency of vitamin D3 in the diet, impaired absorption, calcium deficiency, and lack of exposure to sunlight during periods of rapid growth in children lead to rickets; in adults—to osteomalacia; in pregnant women—to symptoms of tetany and, subsequently, defective enamel formation in children.

Postmenopausal women suffering from osteoporosis due to hormonal imbalances require an increased dose of vitamin D3.

Pharmacokinetics.

Absorption. After oral administration, cholecalciferol is absorbed in the small intestine. The presence of bile facilitates the absorption process. Therefore, impaired liver or gallbladder function and steatorrhea may interfere with the absorption of vitamin D3.

Distribution. Crosses the placental barrier and is excreted into breast milk.

Metabolism. Metabolized in the liver and kidneys, converting into active metabolites. Calcifediol (25-hydroxy-vitamin D3), the product of hepatic hydroxylation of vitamin D3, is the major circulating form of the vitamin, with a half-life of approximately 19 days.

Calcitriol (1,25-dihydroxy-vitamin D3), formed by renal hydroxylation of calcifediol (25-hydroxy-vitamin D3), has a half-life of 3 to 5 days, which may be prolonged in renal disease. It is primarily excreted via bile.

Calcitriol is the active metabolite that binds to a carrier protein and is transported to target organs (intestine, bones, kidneys). Its half-life in blood is several days and may be prolonged in renal disease.

Elimination. Excreted in urine and feces.

Clinical characteristics.

Indications.

• For the prevention of rickets, including in premature newborns;
• for the prevention of vitamin D3 deficiency in high-risk patients who do not have absorption disorders;
• for the prevention of vitamin D3 deficiency in malabsorption;
• for the treatment of rickets and osteomalacia;
• for supportive treatment of osteoporosis.

Contraindications.

Hypersensitivity to the components of the medicinal product, hypercalcemia and/or hypercalciuria, idiopathic neonatal hypercalcemia, hypervitaminosis D, sarcoidosis, renal failure, nephrolithiasis, urolithiasis, tuberculosis.

Pseudohypoparathyroidism (vitamin D requirement may be lower than during normal vitamin sensitivity).

Interaction with other medicinal products and other forms of interactions.

Antiepileptic agents, particularly phenytoin and phenobarbital, as well as rifampicin, neomycin, cholestyramine, and liquid paraffin reduce the effect of vitamin D3.

Concomitant use with thiazides increases the risk of hypercalcemia.

Concomitant use with cardiac glycosides may enhance their toxic effects (increased risk of cardiac arrhythmia).

Concomitant use of the medicinal product with antacids containing aluminum or magnesium may provoke toxic effects of aluminum on bones and hypermagnesemia in patients with renal insufficiency.

Ketoconazole may reduce the biosynthesis and catabolism of 1,25(OH)2 — cholecalciferol.

Concomitant administration of vitamin D3 with metabolites or analogs of vitamin D is possible only as an exception and only under conditions of monitoring serum calcium levels (increased risk of toxic effects).

Concomitant use with medicinal products containing high doses of calcium or phosphorus increases the risk of hyperphosphatemia.

Vitamin D may antagonize medicinal products used in hypercalcemia, such as calcitonin, etidronate, pamidronate.

Concomitant use with weight-reducing agents (orlistat) and cholesterol-lowering agents may reduce the absorption of vitamin D and other fat-soluble vitamins.

Treatment with glucocorticoids may affect vitamin D metabolism.

Special precautions for use

The medicinal product should be used with caution in immobilized patients, patients taking thiazides, cardiac glycosides, and in patients with cardiovascular diseases.

Additional intake of vitamin D3 (concomitant use of other vitamin D-containing preparations) should be taken into account during treatment. Combined therapy with vitamin D or calcium should be administered only under medical supervision, with monitoring of serum and urinary calcium levels.

Individual supplementation to meet specific requirements should take into account all possible sources of vitamin intake.

It should be noted that a diet high in fats may increase the absorption of vitamin D3; therefore, a diet not excessively rich in fats is recommended during administration of the medicinal product.

Very high doses used long-term or bolus doses may lead to chronic vitamin D3 hypervitaminosis.

The determination of a child's daily requirement for vitamin D and the method of administration should be established individually and verified periodically, especially during the first months of life.

The medicinal product should be used with particular caution in infants born with a small anterior fontanelle.

Do not take the medicinal product simultaneously with high doses of calcium.

During treatment with the product, monitoring of serum and urinary levels of calcium and phosphates is recommended.

The medicinal product should be used with caution in patients with impaired renal function. Prolonged use requires monitoring of renal function by measuring serum creatinine levels.

Treatment should be discontinued if symptoms of hypervitaminosis appear: fatigue, nausea, diarrhea, polyuria.

Use during pregnancy or breastfeeding

The medicinal product should be used with caution in pregnant and breastfeeding women.

During pregnancy or breastfeeding, vitamin D should be supplied in adequate amounts. Intake of vitamin D should be monitored.

Daily doses up to 500 IU of vitamin D. Risks associated with vitamin D use within this dosage range are unknown. Prolonged vitamin D overdosage should be avoided due to the potential risk of hypercalcemia.

Daily doses exceeding 500 IU of vitamin D. The medicinal product should be used during pregnancy only if clearly indicated and at strictly recommended doses. Prolonged vitamin D overdosage should be avoided due to the potential risk of hypercalcemia, which may lead to physical and mental developmental abnormalities in the fetus, aortic stenosis, and retinopathy in children.

Vitamin D and its metabolites pass into breast milk; therefore, during breastfeeding, the product should be used only as prescribed by a physician.

There is no data available regarding potential overdose.

Ability to influence reaction rate when driving or operating machinery

There are no reports indicating that the medicinal product affects the ability to drive or operate machinery. However, when driving or operating machinery, particular caution is recommended due to the potential for adverse reactions affecting the nervous system.

Dosage and Administration

The medicinal product is administered orally.

For adults and older children (who are able to swallow a capsule), take the medication orally before or during a meal: swallow the capsule whole with sufficient water (Fig. 1).

(Fig. 1)

For administration to infants from the second week of life, or to adults and older children who cannot swallow a capsule, squeeze the capsule contents into a spoon (container) (Fig. 2) mixed with liquid (milk, fruit juice) or other food.

The capsule contents may also be added to a bottle or plate of food; however, it is essential to ensure complete consumption of the food—otherwise, full dose intake cannot be guaranteed. The medicinal product should be added to food immediately before consumption.

How to release the capsule contents

Prepare a clean spoon (container) (Fig. 2).

Before extracting the capsule contents into a clean spoon (container), thoroughly wash and dry your hands.

With two fingers of one hand, hold the capsule by the tail (for "fish-shaped" capsules) or neck (for "bottle-shaped" capsules) and gently press so that the liquid flows into the body of the capsule (Fig. 3).

With two fingers of the other hand, slightly stretch and firmly squeeze the neck of the capsule (Fig. 4).

Slowly twist the tail or neck until it detaches (Fig. 5). Pay attention to the neck to prevent the contents from squirting out during unscrewing.

After opening the capsule, fully squeeze the liquid into the previously prepared clean spoon (container) (Fig. 6).

(Fig. 2) (Fig. 3) (Fig. 4) (Fig. 5) (Fig. 6)

Prevention of rickets: The recommended dose is 1 capsule of 12.5 mcg (500 IU vitamin D3) daily. Administer as shown in Figs. 2–6, adding the capsule contents to liquid or food as described above.

Prevention of rickets in preterm newborns: The dose is determined by a physician. The general recommended dose is 2 capsules of 12.5 mcg or 1 capsule of 25 mcg (1000 IU vitamin D3) daily. Administer as shown in Figs. 2–6, adding the capsule contents to liquid or food as described above.

Prevention of vitamin D3 deficiency in high-risk patients without malabsorption disorders: The recommended dose is 1 capsule of 12.5 mcg (500 IU vitamin D3) daily. The capsule may be swallowed whole or its contents added to liquid or food as described above.

Prevention of vitamin D3 deficiency in malabsorption conditions: The dose is individually determined by a physician. The general recommended dose is 6–10* capsules of 12.5 mcg or 3–5* capsules of 25 mcg (3000–5000 IU vitamin D3) daily. If the physician prescribes a dose of 4000 IU vitamin D3, administer 1 capsule of 100 mcg (4000 IU vitamin D3) daily. The capsule may be swallowed whole or its contents added to liquid or food as described above.

Treatment of rickets and osteomalacia: The dose is individually determined by a physician depending on the course and severity of the disease. The general recommended dose for treating vitamin D3 deficiency in infants and children is 2–10* capsules of 12.5 mcg (1000–5000 IU vitamin D3) or 1–5* capsules of 25 mcg (1000–5000 IU vitamin D3) daily. If the physician prescribes a dose of 4000 IU vitamin D3, administer 1 capsule of 100 mcg (4000 IU vitamin D3) daily.

Administer by adding the capsule contents to liquid or food as described above. Treatment lasts for one year.

Maintenance treatment of osteoporosis: The recommended dose is 2 capsules of 12.5 mcg (1000 IU vitamin D3) or 1 capsule of 25 mcg (1000 IU vitamin D3) daily. The capsule may be swallowed whole or its contents added to liquid or food as described above.

Duration of treatment.

The duration of treatment depends on the course and severity of the disease and is individually determined by a physician.

Treatment of rickets and osteomalacia caused by vitamin D3 deficiency lasts for one year.

Children are prescribed the medicinal product for rickets prevention starting from the second week of life until the end of the first year of life. During the second year of life, continued use of the medication may be necessary, especially during winter months.

When doses exceeding 1000 IU vitamin D3 daily are used, as well as during continuous or long-term treatment, regular monitoring of blood creatinine levels and serum and urinary calcium levels is recommended. If necessary, the dose should be adjusted based on serum calcium concentration.

*For high-dose cholecalciferol requirements, it is recommended to use the medicinal product in another pharmaceutical form with a higher dosage strength.

Children. The product is indicated for children from the second week of life.

Overdose.

Vitamin D3 regulates calcium and phosphate metabolism. Overdose may lead to hypercalcemia, hypercalciuria, renal calcifications, bone damage, and cardiovascular system changes. Hypercalcemia may occur after daily intake of 50,000–100,000 IU vitamin D3.

Symptoms of overdose may include: muscle weakness, loss of appetite, nausea, vomiting, constipation, polydipsia, polyuria, drowsiness, photophobia, pancreatitis, rhinorrhea, hyperthermia, decreased libido, conjunctivitis, hypercholesterolemia, increased transaminase activity, arterial hypertension, cardiac arrhythmia, and uremia. Common symptoms include: muscle and joint pain, headache, weight loss. Renal dysfunction may develop, with albuminuria, erythrocyturia, polyuria, increased potassium loss, hypostenuria, nocturia, and moderate increase in blood pressure.

In severe cases, corneal clouding may occur; rarely, optic disc edema, uveitis, and even cataract development may occur.

Kidney stones may form, and calcification may occur in soft tissues such as blood vessels, heart, lungs, and skin.

Cholestatic jaundice may rarely develop.

Treatment. Overdose requires treatment of hypercalcemia. Discontinue the medicinal product. Depending on the degree of hypercalcemia, a low-calcium or calcium-free diet, high fluid intake, forced diuresis induced by furosemide, and administration of glucocorticoids and calcitonin are recommended.

In patients with normal renal function, calcium levels can be significantly reduced by intravenous infusion of sodium chloride solution (3–6 liters within 24 hours) combined with furosemide. In some cases, 15 mg/kg body weight/hour of sodium edetate may also be administered, with continuous monitoring of calcium levels and ECG. In cases of oligoanuria, hemodialysis is required. There is no specific antidote.

Adverse Reactions.

Adverse reactions are usually not observed when the product is used at recommended doses.

In rare cases, individual hypersensitivity to the drug may occur, or symptoms of vitamin D overdose may develop as a result of prolonged use of very high doses.

Cardiovascular system: arrhythmia, arterial hypertension.

Gastrointestinal tract: loss of appetite, nausea, vomiting, constipation, dry mouth, flatulence, abdominal pain, diarrhea, dyspepsia, pancreatitis.

Nervous system: headache, drowsiness, psychiatric disturbances, depression.

Urinary system: elevated calcium levels in blood and/or urine, nephrolithiasis and tissue calcification, uremia, polyuria.

Skin: hypersensitivity reactions, including urticaria, rash, pruritus.

Musculoskeletal system: myalgia, arthralgia, muscle weakness.

Eyes: conjunctivitis, photophobia.

Metabolism and nutrition: hypercholesterolemia, weight loss, polydipsia, increased sweating.

Hepatobiliary system: increased aminotransferase activity.

Psychiatric disorders: decreased libido.

There have also been reports of rhinorrhea, hyperthermia, and dry mouth.

Shelf life: 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

Capsules of 12.5 mcg (500 IU) and 25 mcg (1000 IU)

10 capsules per blister pack; 6 blisters per carton.

Capsules of 100 mcg (4000 IU)

10 capsules per blister pack; 3 blisters per carton.

Availability: Over-the-counter (without prescription).

Manufacturer: JSC "KYIV VITAMIN PLANT".

Manufacturer's address and location of business activity:

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua